AMICAR (Page 2 of 2)

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate the carcinogenic potential of AMICAR and studies to evaluate its mutagenic potential have not been conducted. Dietary administration of an equivalent of the maximum human therapeutic dose of AMICAR to rats of both sexes impaired fertility as evidenced by decreased implantations, litter sizes and number of pups born.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with AMICAR. It is also not known whether AMICAR can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AMICAR should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AMICAR is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

AMICAR is generally well tolerated. The following adverse experiences have been reported:

General: Edema, headache, malaise.

Hypersensitivity Reactions: Allergic and anaphylactoid reactions, anaphylaxis.

Cardiovascular: Bradycardia, hypotension, peripheral ischemia, thrombosis.

Gastrointestinal: Abdominal pain, diarrhea, nausea, vomiting.

Hematologic: Agranulocytosis, coagulation disorder, leukopenia, thrombocytopenia.

Musculoskeletal: CPK increased, muscle weakness, myalgia, myopathy (see WARNINGS), myositis, rhabdomyolysis.

Neurologic: Confusion, convulsions, delirium, dizziness, hallucinations, intracranial hypertension, stroke, syncope.

Respiratory: Dyspnea, nasal congestion, pulmonary embolism.

Skin: Pruritis, rash.

Special Senses: Tinnitus, vision decreased, watery eyes.

Urogenital: BUN increased, renal failure. There have been some reports of dry ejaculation during the period of AMICAR treatment. These have been reported to date only in hemophilia patients who received the drug after undergoing dental surgical procedures. However, this symptom resolved in all patients within 24 to 48 hours of completion of therapy.

OVERDOSAGE

A few cases of acute overdosage with AMICAR administered intravenously have been reported. The effects have ranged from no reaction to transient hypotension to severe acute renal failure leading to death. One patient with a history of brain tumor and seizures experienced seizures after receiving an 8 gram bolus injection of AMICAR. The single dose of AMICAR causing symptoms of overdosage or considered to be life-threatening is unknown. Patients have tolerated doses as high as 100 grams while acute renal failure has been reported following a dose of 12 grams.

The intravenous and oral LD50 of AMICAR were 3.0 and 12.0 g/kg, respectively, in the mouse and 3.2 and 16.4 g/kg, respectively, in the rat. An intravenous infusion dose of 2.3 g/kg was lethal in the dog. On intravenous administration, tonic-clonic convulsions were observed in dogs and mice.

No treatment for overdosage is known, although evidence exists that AMICAR is removed by hemodialysis and may be removed by peritoneal dialysis. Pharmacokinetic studies have shown that total body clearance of AMICAR is markedly decreased in patients with severe renal failure.

DOSAGE AND ADMINISTRATION

An identical dosage regimen may be followed by administering AMICAR Tablets or AMICAR Oral Solution as follows:

For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 5 AMICAR 1000 mg Tablets or 10 AMICAR 500 mg Tablets (5 g) or 20 milliliter of AMICAR Oral Solution (5 g) be administered during the first hour of treatment, followed by a continuing rate of 1 AMICAR 1000 mg Tablet or 2 AMICAR 500 mg Tablets (1 g) or 5 milliliter of AMICAR Oral Solution (1.25 g) per hour. This method of treatment would ordinarily be continued for about 8 hours or until the bleeding situation has been controlled.

HOW SUPPLIED

Product: 68151-3023

NDC: 68151-3023-1 1 TABLET in a BLISTER PACK

REFERENCE

1 Stefanini M, Dameshek W: The Hemorrhagic Disorders, Ed. 2, New York, Grune and Stratton; 1962:510-514.

Marketed by
Logo
Marietta, GA 30062

Code 909B00
Rev. 05/15

AMICAR (AMINOCAPROIC ACID) SOLUTION AMICAR (AMINOCAPROIC ACID) TABLET

Label ImageLabel Image
AMICAR
aminocaproic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-3023(NDC:49411-050)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMINOCAPROIC ACID (AMINOCAPROIC ACID) AMINOCAPROIC ACID 500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE, UNSPECIFIED
CROSPOVIDONE (15 MPA.S AT 5%)
STEARIC ACID
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 13mm
Flavor Imprint Code XP;A;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-3023-1 1 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA015197 06/01/2015
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-3023)

Revised: 08/2018 Carilion Materials Management

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.